Medicine / 15. Neonatology
Scientific research
Institute of Obstetrics and Pediatrics, Russia
Rostov-on-Don
Effectiveness of SELENASE®
in therapy of the respiratory distress syndrome (SDR) of the newborn babies and
its influence on the manifestation of systemic inflammatory response syndrome
(SIRS)
Until now, one of the most
difficult problem of neonatology is the treatment of the septic-purulent
phenomenon, complicating the course in neonatal respiratory distress syndrome
[1, 2]. In this connection, the search for new approaches to diagnosis and
treatment of sepsis is perspective. Moreover, analysis of published data
indicates that the use of selenium-containing preparations contribute not only
reducing SIRS, but also reducing the severity of sepsis [3, 4, 5]. The latter
circumstance served as an the impetus for this study.
The aim of the study was to test the hypothesis that the use of
sodium selenite pentahydrate (drug Selenase ®, Biosyn, Germany) in the
conducted standard intensive care,which was adopted in the intensive care
department pediatric anesthesiology and resuscitation (DPAR) of
the Rostov Scientific Research Institute of Obstetrics and Pediatrics, will
reduce the incidence of SIRS (sepsis ) of the newborns babies with perinatal
lesion (PP CNS) and SDR, who are on the pulmonary artificial ventilation
(AVP). Patients
and methods: according to the design, there were examined 76 newborn
babies with the respiratory distress syndrome. Children were born in the
critical condition, demanding the organizing of the primary reanimation
measures (order number 372 Ministry of Public Health, Russia), with the Apgar
scores 3,1 ± 1,1 gestational age 39,1 ± 1,1 weeks, body weight 3350 ± 250
g, translated to the mechanical ventilation in the delivery room and entering
in the intensive care unit in of the first 48 hours of life.
Study was carried out in an ethical aspect. In the
intensive care department (DPAR), the children were divided into 2 groups.
Randomization was carried out by a computer program of random number generator
by the number of a case history. Group I (n = 36), the even-numbered stories of
disease got selenase (Selenase ®, Biosyn) at a dose of 10 mcg/ kg/day
intravenously slowly for 10 days, and Group two (n = 40) - odd-numbered, was
the control group. Probationers I and second group received
standard intensive therapy, adopted in the intensive care
department
and the severity of the condition of the disease. Upon admission in probations,
no child had no signs of the septic infection. For clinical diagnosis
"sepsis", we used a combination of at least two symptoms of SIRS,
with the the obligatory presence of any pyoinflammatory hearth, with positive
blood cultures, or the presence of clinical signs of infection. It should be
noted that all the newborns included in the study, upon admission, as well as
on 3-5 days , 10 days, or in the outcome of the disease, as by indications
there were examined: total blood count (performed on an automated hematology
analyzer "CelltacF" MEK - 8222J / K, Japan, daily), blood chemistry
(total protein, carbamide, creatinine), procalcitonin test, C - reactive
protein (CRP), early apoptosis, late apoptosis and produced a comprehensive bacteriological examination blood
cultures, urine, swabs from the umbilical wound, eyes, nose, throat, trachea,
flushing of the endotracheal tube, liquor (if necessary) (in order to determine
the identification of pathogens and antibiotic susceptibility). Analysis and
statistical processing of the data was performed using standard software
packages "Megastat" and Statistica-6. Results were considered
significant for values of the type I error of p < 0, 05.
Results: sepsis as a complication of the underlying disease, developed in 11
(14.47%) patients from 76 patients included in the study.
Moreover, in group I (treated by selenase) sepsis occurred in 2 (2.6%) infants,
while in group two (II), in 9 (11.8%) patients. It should be noted that in 3
(4%) of 9 patients, the second group had the place to be transplacental
infection sepsis (fetal sepsis), which is more
severe, in the form septicopyemia, with symptoms of purulent meningitis,
meningoencephalitis, bilateral pneumonia, as well as the phenomena of
endotoxemia and multiorgan failure (MOF).
The rest of the children,
of both groups developed acute neonatal sepsis in the form of septicemia
(10.5%). In order to test the hypothesis that the selenase use conducted in
intensive care standard, adopted in the department, reduces the incidence of
SIRS (sepsis), performed detailed calculation of the criterion F (Fisher-Irwin)
for bilateral alternatives at the 5% significance level (Table 1).
Table
1
Distribution and calculation of criteria F (Fischer-Irwin)
|
Group |
Fisher-Irwin criterion |
||
|
sepsis |
no sepsis |
Total |
|
|
I - Group |
2 |
34 |
36 |
|
II - Group |
9 |
31 |
40 |
|
Total |
11 |
65 |
76 |
When calculating this
criterion, the following result was received: p = 0,0358, which once
again confirms the validity and reliability of the obtained values.
Thus, in our study
conclusive, statistically significant evidence was obtained that, using
selenase, is not only a significant decrease (4.5-fold) (p < 0.05)
the incidence of sepsis in infants with the respiratory distress syndrome and
perinatal CNS on mechanical ventilation, but also reducing the severity of
sepsis.
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